Another reason for opening this conversation, according to the FDA, is to help set clearer lines defining manufacturer obligations and distinguishing them from third-party obligations.

OEMs have requested clarification with regard to their responsibilities when third-parties repair, service, or refurbish devices they manufactured. While, for its part, the FDA said it is "interested in learning more about the challenges third-party entities face in maintaining or restoring devices to their original specifications."


The following seven questions are posed in the docket. Answers submitted will help the FDA evaluate risks associated with the activities it is hoping to refine its definitions of.

1. Who are the different stakeholders involved with the medical device activities listed previously? What are their respective roles?

2. What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities? Specific examples should be submitted.

3. What are the potential risks (patients/users) and failure modes (devices) introduced as a result of performing the previously defined activities on medical devices? Please speak to issues common to all devices as well as specific risks with specific devices.

4. These activities are performed by OEMs and various third-party entities, including hospitals and humanitarian organizations. Are the risks different depending on who performs the previously mentioned activities?

5. We are interested in knowing if these activities are more difficult or riskier to perform on certain devices versus others. Please cite specific examples in your response, along with an explanation of the source of this particular complexity.

6. What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device? Please provide specific examples.

7. What additional challenges do stakeholders encounter with devices that result from these activities?

At this point it is too early to tell what the repercussions of this docket might be, but the FDA has stated that the core interest propelling the discussion is patient safety. In addition, the FDA said it will hold a public meeting later in the year in order to further engage stakeholders on these terms.

To view the docket on the FDA website or contribute comments to it, click here and enter "FDA-2016-N-0436" into the search bar. HCB News will be following the FDA and reporting on new developments as they happen.

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